Kornimate/medical-research-clean huggingface dataset:
a prospective, multicenter, post-marketing clinical follow-up research to evaluate the long-term safety of ellansé-s dermal filler made of pcl microspheres for the correction of moderate-to-severe nasolabial folds

Conditions: Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face

Summary: this research is intended to evaluate the long-term safety of ellansé-s pcl dermal filler for the correction of moderate-to-severe nlfs. 374 subjects. this clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of pcl microspheres, for the correction of moderate-to-severe nlfs


Eligibility criteria:
inclusion criteria: 1. 18 years old and above; 2. subjects with moderate-to-severe nasolabial folds (3-4 level of wsrs scores) on both sides of the face 3. intended to be treated with pcl microsphere filler; 4. voluntarily participate in this test, cooperate with follow-up, and sign an informed consent form exclusion criteria: 1. obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area; 2. patients who have used permanent fillers (pmma, hydrogel polymer, liquid silicone for injection, polyvinyl alcohol (pva), bone cement, autologous fat, etc.) for nasolabial groove injection; 3. patients who have received semi-permanent fillers (polycaprolactone, l-polylactic acid, hydroxyapatite, platelet-rich plasma, etc.) injection treatment in nasolabial sulch area in the past 24 months; 4. patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months; 5. patients who have received botox injection treatment in nasolabial sulci in the past 6 months; 6. the nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months; 7. use of hormones or immunosuppressants within the past 1 month; 8. subjects who have used anticoagulants in the last 2 weeks; 9. subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution; 10. subjects with active sepsis; 11. subjects with coagulation dysfunction; 12. subjects with autoimmune diseases; 13. allergic to polycaprolactone or known product ingredients; 14. pregnant, pregnant and lactating subjects; 15. participated in other clinical trials in the past 30 days; 16. other situations determined by the researcher to be unsuitable for participation in this study;
water filter study in ciudad victoria

Conditions: Waterborne Diseases; Diarrhea

Summary: this study measures effects of water filters and filter types on household health in ciudad victoria, mexico.

a project to assess the water quality in ciudad victoria, mexico and the effectiveness of different sawyer pointone filter types (bucket, tap, squeeze) . the project is designed to 1) assess the impact of filters on health and well-being of families, 2) assess the impact of filters on the economic status of families and 3) compare different filter formats for use/adoption on the above metrics. the project will provide information about how well the different filters are working in urban households in a middle-income latin american country, make recommendations for future deployment of filter types in similar settings, and determine the potential for scaling the use of filter systems to provide clean drinking water for people in need in future projects.

Eligibility criteria:
inclusion criteria: * recruiting will occur in ciudad victoria, mexico at any household in the areas surveyed exclusion criteria: * none, except those who decline the survey and/or filter
effect of non surgical treatment of periodontitis on diabetes control

Conditions: Periodontitis; Diabetes

Summary: the aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. the treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. glycated haemoglobin (hba1c) and c-reactive protein (crp) will be analysed at baseline and three months following enrolment.

the aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. the treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. glycated haemoglobin (hba1c) and c-reactive protein (crp) will be analysed at baseline and three months following enrolment.

Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least one year * periodontitis * hba1c \> 7% exclusion criteria: * periodontal treatment in the last 6 months * antibiotics in the last 3 months * tobacco smoking * pregnancy

Keywords: periodontitis diabetes hba1c inflammation
bgm and hba1c poc device evaluation

Conditions: Diabetes

Summary: this study aims to assess analytical performance of four bgms and four hba1c poc devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for bgms only). system usability will also be assessed for all bgms (including lancing devices) and hba1c devices.


Eligibility criteria:
inclusion criteria: arm 1: * 13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total arm 1 population) •≥18 years, diagnosed with diabetes * able and willing to provide informed consent/assent * naïve to the smbg use of the investigational devices * 10% naïve to any smbg (defined as not having performed any smbg in the last 24 months) * haematocrit within 20-60% * pre-screen bgm result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range arm 2: •≥18 years * able and willing to provide informed consent * diagnosed or not diagnosed with diabetes * haemoglobin values ≥ 8g/dl * pre-screen hba1c result qualifies for inclusion in the target hba1c range and % of subjects required for the mid-range values exclusion criteria: arm 1: * \<13 years * 13-17 years and not diagnosed with diabetes or unable to manage condition independently * previous use of investigational bgm for smbg * haematocrit outside normal range * pre-screen bgm result falling in a glucose concentration range that already has sufficient participants. arm 2: * \<18 years * haemoglobin value \< 8g/dl * pre-screen hba1c result falling in a concentration range that already has sufficient participants.
subacute thyroiditis in the sars-cov-2 era

Conditions: Subacute Thyroiditis; SARS CoV 2 Infection; Thyrotoxicosis

Summary: many cases of subacute thyroiditis (sat) have been described related to sars-cov-2 infection, but no prospective data about follow-up is known. this prospective, longitudinal, 3-year, multicentre study is aimed at exploring clinical peculiarities and outcome of sat in relation to sars-cov-2 infection, ascertained with antibody dosage. all patients receiving sat diagnosis from november 2020 to may 2022 were enrolled. multicentre study. data about anamnesis, physical examination, blood tests (tsh, freet4, freet3, thyroglobulin, anti-thyroid antibodies, c-reactive protein, erythrocyte sedimentation rate, complete blood count), and thyroid ultrasound were collected. at baseline, the presence of igg against the sars-cov-2 spike protein or nucleocapside was investigated. patients were evaluated after 1, 3, 6, 12 months.

a multicentre, longitudinal, prospective study was conducted, enrolling all patients diagnosed with sat at the participating centres between november 2020 and may 2022. the following italian centres participated: endocrinology unit of azienda ospedaliero-universitaria of modena (coordinating center); endocrinology unit of irccs ca' granda ospedale maggiore policlinico of milano; endocrinology and diabetes prevention and care unit of the irccs azienda ospedaliero-universitaria policlinico of bologna. these units were involved through a call launched by the coordinating center to the young italian members of the club engioi (endocrinologia giovane in italia) of the italian society of endocrinology (sie). five visits were planned: at diagnosis (v0) and after 1, 3, 6 and 12 months (v1, v2, v3 and v4, respectively). at each visit, subjects were evaluated with anamnesis, physical examination, thyroid ultrasound and blood tests. patients were treated according to the clinical presentation and to the current guidelines. nonsteroidal anti-inflammatory drugs (nsaids) were preferred in patients with mild symptoms and mild laboratory findings; steroid therapy was preferred in those with severe symptoms and/or those who did not respond to nsaids within 1 to 2 weeks. beta-blockers were prescribed as symptomatic treatment in case of tachycardia. during the follow-up phase, the therapeutic approach and any change of it were recorded. finally, the treatment responsiveness and outcomes of transient hypothyroidism, permanent hypothyroidism, or recurrence during the follow-up period were all documented.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of subacute thyroiditis * age ≥ 18 years * willingness to sign an informed consent exclusion criteria: * ongoing pregnancy * alcohol abuse.
effects of walking apnea at low lung volume on hypoalgesia

Conditions: Pain; Hypoxemia; Hypercapnia; Apneas

Summary: the aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria:
inclusion criteria: * asymptomatic subjects aged between 18 and 64 years. exclusion criteria: * cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies. * history of epilepsy. * pregnant * pharmacological treatment. * participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
tidal volume challenge and lung recruitment maneuver (tidalrec): the reliability of pulse pression variation or stroke volume variation on fluid responsiveness.

Conditions: Fluid Challenge; Hemodynamic Monitoring

Summary: in order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the tidal volume challenge (vtc) and the lung recruitment maneuver (lrm). the objective is to determine whether the variation of 2 parameters such as pulse pression variation (ppv) and stroke volume variation (svv) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. all patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. the order of the ventilation strategies will be determined by randomization.


Eligibility criteria:
inclusion criteria: * patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of svv and ppv with placement of a radial arterial catheter connected to the proaqt® system. * block duration \> 2 hours. exclusion criteria: * open surgery * history of supra ventricular arrhythmias * beta-blocking patient * bmi\>30 kg.m-2 or \<15 kg.min-2 * right ventricular dysfunction * severe valvulopathies * intracardiac shunt * renal failure dialysis * patient's refusal

Keywords: tidal volume challenge lung recruitment maneuver pulse pression varia-tion stroke volume variation. fluid responsiveness.
efficacy and safety of precision therapy in refractory tumor

Conditions: Rare Tumor; Refractory Tumor

Summary: this study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

the individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. all patients have no any standard therapy based on nccn guideline when recruiting. next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. pd-1/l1 inhibior plus anti-angiogenic agent was used in patients without durgguable targets. the efficacy and safety of these regimens were evaluated.

Eligibility criteria:
inclusion criteria: * malignant solid tumors diagnosed histologically; * common solid tumor patients have no any standard choice after multiple line of therapy; rare solid tumor did not have any standard recommended treatment; * expected survival ≥ 1 month; * ecog / ps score: 0-2, and the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln); liver alt and ast \<2.5 × uln and if liver metastases, alt and ast \<5 × uln; serum cr ≤ 1 × uln, endogenous creatinine clearance ≥50ml/min exclusion criteria: * patient still has standard treatment therapy based on nccn guidance; * patient can not comply with research program requirements or follow-up;
outpatient oncology aromatherapy for symptom management

Conditions: Anxiety; Nausea

Summary: the purpose of this research study is to determine whether using aromatherapy during chemotherapy infusion treatments in the outpatient oncology setting promote relief of nausea and anxiety. the objectives of this study are: 1. to promote relief of nausea using peppermint aromatherapy oil in an outpatient oncology setting. 2. to promote relief of anxiety using lavender aromatherapy oil in an outpatient oncology setting.

subject selection: every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital-approved aromatherapy of peppermint oil or lavender oil. if patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. informed consent will then be obtained by co-investigators or principal investigator of the study. the consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients. method of subject identification and recruitment: every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital- approved aromatherapy of peppermint oil or lavender oil. if patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. informed consent will then be obtained by co-investigators or principal investigator of the study. the consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.

Eligibility criteria:
inclusion criteria: all outpatient oncology patients \> 18 years of age non pregnant not cognitively impaired english speaking only patients who report nausea and/or anxiety exclusion criteria: all outpatient oncology patients \<18 years of age pregnant cognitively impaired non-english speaking patients who do not report nausea and/or anxiety patients with a known allergy to peppermint and/or lavender aromatherapy oil
reference interval for spo2 in neonates at high altitudes during first 2 hours and umbilical artery blood gas

Conditions: Neonatal Disease; Altitude Hypoxia

Summary: pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. during postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. as a result, postnatal transition may be different at high altitudes. umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. but there are only limited studies about the spo2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. the primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. the secondary outcomes is to establish the ph and lactate cutoff value of umbilical arterial blood gas at different altitude level.


Eligibility criteria:
inclusion criteria: * infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by: 1. normal vital signs (heart rate ranging from 110 to 180 beats/minute, respiratory rate ranging from 30 to 60 breaths/minute, temperature ranging from 36.5°c to 37.5°c), 2. absence of signs of illness such as respiratory distress. 3. the mothers resided in the study area. exclusion criteria: * outborn, require resuscitative interventions at birth beyond blow-by oxygen, * require admission for any reason other than observation or had a major congenital anomaly.

Keywords: pulse oxygen saturation neonate altitude umbilical arterial blood gas
basics in acute shortness of breath evaluation (basel v) study

Conditions: Dyspnea

Summary: to improve the diagnostic and prognostic utility of various biomarkers, detailed patient's history, physical examinations and technical devices in patients presenting with acute dyspnea.

background: acute heart failure is a common disease associated with high morbidity and mortality. unfortunately, pathophysiology and optimal initial treatment are both ill defined. working hypothesis: * improved understanding of the pathophysiology underlying heart failure might allow more cause-specific treatment to this syndrome. * more rapid diagnosis of acute heart failure may allow to more rapidly initiate the appropriate treatment. * cardiac dysfunction especially in comorbid dyspneic patients is not adequately characterized and the spectrum of acute heart failure is more diverse than originally thought. methods: this is a large multicenter center, observational study enrolling unselected, consecutive patients with acute dyspnea presenting to the emergency department. patient history, physical examination and laboratory parameters will be systematically obtained. echocardiographic examinations will be routinely performed. follow-up will be done at specified intervals (3, 6 and 12 months) after the initial presentation and risk predictors will be analyzed in multivariable regression models. expected value of the proposed project: the data obtained during this project will help to further improve diagnostics and prognostics in patients with acute dyspnea and to better understand underlying pathology of cardiac dysfunction in this cohort. significance: the study aims are up-to-date and deal with an important health care problem in society. conclusions drawn will significantly change care of patients with acute heart failure probably leading to a significant reduction of rehospitalization, morbidity and mortality.

Eligibility criteria:
inclusion criteria: * chief complaint of dyspnea (not penetrating injury or trauma related) * subjects must be at least 18 years of age exclusion criteria: * patient is unable or unwilling to give informed consent * patient on hemodialysis

Keywords: heart failure bnp acute dyspnoea